(162 days)
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.
Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.
The provided K091512 document is a 510(k) summary for a dental restorative material called "Build-It Light Cure." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about specific acceptance criteria or a detailed study proving the device meets quantified performance benchmarks.
The document discusses the device's technical characteristics, its intended use, and its equivalence to an existing device (Clearfil Photo Core). It does not present data from a study designed to evaluate the performance against predefined acceptance criteria for attributes like cure depth, strength, or other material properties.
Therefore, I cannot provide the requested information. The document focuses on regulatory submission and equivalence rather than a detailed performance study with acceptance criteria.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.